Trial NCT04406909
Publication Bretthauer M, medRxiv, 2020
Funding: Public (Norwegian Research Council (grant no. 312757))
| Methods | |
| RCT | |
| Location :
Multicenter / Norway Follow-up duration (days): 21 | |
| Inclusion criteria | All members of the five participating training facilities age 18 years or older who are not atincreased risk for severe COVID-19 disease per criteria by the Norwegian Institute of PublicHealth, were eligible for participation. The criteria for high risk are at least one of thefollowing: age 65 years or older; cardiovascular disease including hypertension; diabetes(https://www.fhi.no/nettpub/coronavirus/fakta/risikogrupper/, accessed May 15, 2020). |
| Exclusion criteria | increased risk for severe COVID-19 disease per criteria by the Norwegian Institute of Public Health, were eligible for participation. The criteria for high risk are at least one of the following: age 65 years or older; cardiovascular disease including hypertension; diabetes (https://www.fhi.no/nettpub/coronavirus/fakta/risikogrupper/, accessed May 15, 2020). |
| Interventions | |
| Treatment
Social distancing at sports training facilities (*) Duration : 21 days |
|
| Control
No access to sports training facilities Duration : 21 days | |
| Participants | |
| Randomized 3764 participants (n1=1868 / n2= 1896) | |
| Characteristics of participants N=3764 Mean age : NR 1835 males | |
| Primary outcome | |
| In the register 1. COVID-19 RNA test positivity [ Time Frame: At the end of Cycle 1 (cycle length is 14 days) ] Percentage of COVID-19 RNA positive individuals2. Hospital admission for COVID-19 [ Time Frame: 7 days after the end of Cycle 1 (cycle length is 14 days) ] Percentage of people admitted to hospital for COVID-19 | |
| In the report | |
| Documents available |
Protocol NR Statistical plan NR Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
High |
| General comment | In addition to all available versions of the published article, the study registry was used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The article referenced a protocol but it could not be found. The trial did not achieve the planned sample size reported in the trial registry. |